This standard establishes the minimum requirements for the independent audit and certification of research peptide products by the Global Institute for Biomedical Quality (GIBQ). It applies to vendors seeking the GIBQ Verified certification seal and applies to all peptide compounds intended for research use.
This standard does not apply to pharmaceutical-grade peptide drugs regulated by the FDA or equivalent national authorities, or to in-house research synthesis. Vendors whose products are subject to existing pharmaceutical regulatory frameworks should consult applicable regulatory guidance in addition to this standard.
The following documents are referenced in this standard. Where dated, only the edition cited applies.
- United States Pharmacopeia (USP) General Chapter <232>: Elemental Impurities — Limits
- United States Pharmacopeia (USP) General Chapter <71>: Sterility Tests
- United States Pharmacopeia (USP) General Chapter <85>: Bacterial Endotoxins Test
- ICH Q3D: Guideline for Elemental Impurities
- GIBQ Label Standard, Version 1.0 — gibq.org/standards/label-standard-v1
A document issued by an accredited independent laboratory confirming that a product lot has been tested against specified criteria and meets defined acceptance criteria.
The certification status awarded to a specific product lot upon successful completion of a GIBQ independent audit demonstrating conformance with all seven points of this standard.
For purposes of this standard, an accredited independent laboratory is a testing facility that (a) is not owned, controlled, or operated by the vendor submitting documentation for audit; (b) holds current accreditation from a nationally recognized accreditation body; and (c) conducts testing using validated, published analytical methods appropriate to each test type specified herein.
A defined quantity of a specific peptide compound produced under uniform conditions, identified by a unique lot number, for which a complete COA has been issued.
For a product lot to receive GIBQ Verified certification, the submitted COA must demonstrate conformance with all seven of the following points. Each point must be supported by results from an accredited independent laboratory.
| Point | Test | Method | Acceptance Criterion |
|---|---|---|---|
| 1 | Identity | RP-HPLC | Confirmed compound match to reference standard |
| 2 | Purity | HPLC | ≥ 99.0% by peak area |
| 3 | Net Content | Gravimetric / HPLC | ≥ 95% of labeled amount |
| 4 | Endotoxin | LAL Test | < 1 EU/mg |
| 5 | Sterility | Filtration + Incubation | No microbial growth detected |
| 6 | Heavy Metals | ICP-MS | All elements below USP <232> limits |
| 7 | Label & Packaging Compliance | Documented review against GIBQ Label Standard | Required elements present, no prohibited elements |
Point 7 label evaluation is conducted against the GIBQ Label Standard.
Vendors submit the following documentation for each product lot seeking certification: (a) complete COA from an accredited independent laboratory, (b) product label or label image, and (c) laboratory accreditation credentials for the issuing facility.
GIBQ independently reviews submitted documentation against each of the seven points defined in Section 4. GIBQ does not conduct laboratory testing. The audit is a documentary review of results produced by the vendor's designated testing laboratory.
Certification requires conformance with all seven points. A product lot that fails any single point does not qualify for the GIBQ Verified certification. Vendors may re-submit with updated documentation at any time.
Passing product lots receive a numbered GIBQ Certificate of Verification in the format GIBQ-YYYY-NNNN. The certificate is valid for twelve months from the date of issue, subject to no material change in formulation, manufacturing process, or testing laboratory.
All GIBQ Verified product lots are listed in the publicly accessible GIBQ Registry. Each listing displays the certificate number, vendor name, compound name, number of certified SKUs, audit date, and current status. The registry is updated upon certification, expiry, or revocation of any certificate.
Certificate status may be set to Active, Expired, or Revoked. A revoked certificate indicates that GIBQ has determined the basis for certification is no longer valid. The reason for revocation is noted in the registry record.
GIBQ maintains strict separation between its certification function and any commercial interest in the peptide supply chain. GIBQ does not manufacture, distribute, or resell peptide compounds. Any person conducting a GIBQ audit must disclose and recuse themselves from any audit in which a conflict of interest exists.
This standard is versioned. Each revision is published as a new, numbered version at its own permanent address, with a summary of changes recorded in Section 8. Once published, a version is never altered, and every prior version remains publicly available for reference.
| Version | Date | Summary of Changes |
|---|---|---|
| 1.0 | April 2026 | Initial publication. Seven-point verification standard established. Point 7 references GIBQ Label Standard for detailed label evaluation criteria. |
| 1.1 | September 2026 | Removed references to a Scientific & Regulatory Advisory Board, which has not been formed. Section 7 now describes how revisions to this standard are published. No change to the seven verification points or their criteria. |
| 1.2 | September 2026 | Certificate number format updated to GIBQ-YYYY-NNNN (four-digit sequence). No change to the seven verification points, their criteria, or any other section. |
Issued by: Global Institute for Biomedical Quality
Publication Date: September 22, 2026
Revisions to this standard are published as new versions. Versions 1.0 and 1.1 remain available at gibq.org/standards/seven-point-standard/v1 and /v1.1.